The RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux

Pediatrics. 2013 Jul;132(1):e34-45. doi: 10.1542/peds.2012-2301. Epub 2013 Jun 10.


Background and objective: Vesicoureteral reflux (VUR) is diagnosed in ∼30% to 40% of children who have imaging studies after urinary tract infections (UTIs). Our goal is to characterize children enrolled in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial and to compare our study cohort with those from previously published studies.

Methods: RIVUR investigators from 19 pediatric sites in the United States recruited 607 children with grade I through IV VUR. Children were enrolled after a first or second UTI. This cross-sectional report of baseline data includes extensive clinical, parental report, and imaging study results.

Results: RIVUR recruited 607 children (558 girls, 49 boys) with grade I (11%), II (42%), III (38%), or IV (8%) reflux. The median age was 12 months, and most children (91%) were enrolled after their first UTI. The UTI leading to enrollment was both febrile and symptomatic for 323 children, febrile only in 197 children, and symptomatic only in 86. Renal involvement at baseline as documented by a (99m)Tc dimercaptosuccinic acid scan was uncommon with cortical defects identified in 89 (15%) children. Bladder and bowel dysfunction was identified in 71 (56%) of 126 toilet-trained subjects assessed.

Conclusions: RIVUR is the largest prospective, randomized trial for children with primary VUR to date, comparing prophylaxis with placebo. The study sample comprises patients from 19 pediatric clinical sites in the United States, whose demographic and clinical characteristics may differ from those of children enrolled in previous trials from other countries.

Trial registration: NCT00405704.

Keywords: clinical research/trials; renal scarring; urinary tract infections; vesicoureteral reflux (VUR).

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Anti-Infective Agents, Urinary / adverse effects
  • Anti-Infective Agents, Urinary / therapeutic use*
  • Child, Preschool
  • Cohort Studies
  • Cross-Sectional Studies
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Kidney Cortex / pathology
  • Long-Term Care
  • Male
  • Mass Screening
  • Patient Selection
  • Prospective Studies
  • Secondary Prevention
  • Technetium Tc 99m Dimercaptosuccinic Acid
  • Trimethoprim, Sulfamethoxazole Drug Combination / adverse effects
  • Trimethoprim, Sulfamethoxazole Drug Combination / therapeutic use*
  • Ultrasonography
  • United States
  • Urinary Tract Infections / diagnosis
  • Urinary Tract Infections / drug therapy*
  • Urography
  • Vesico-Ureteral Reflux / diagnosis
  • Vesico-Ureteral Reflux / drug therapy*


  • Anti-Infective Agents, Urinary
  • Technetium Tc 99m Dimercaptosuccinic Acid
  • Trimethoprim, Sulfamethoxazole Drug Combination

Associated data